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FDA To Strengthen Public Warnings On Voluntary Recalls


Voluntary recalls are implemented by companies in collaboration with their partners in the supply chain with the objective of removing product from shelves as quickly as possible.

The FDA is concerned that additional warnings are required to protect consumers. Following a January 2018 announcement, the FDA issued a draft guidance document requiring companies to disclose retail information on recalled products. A guidance was issued on mandatory recall of foods was finalized in November 2018. On February 7th, the FDA released the Final Rule issued under 21CFR Part 7 describing when the FDA would issue a public warning and describes the general timeframe for companies to issue their own warning including content. The FDA will monitor recalls in accordance with an Enforcement Report.

During the past 12 months, the FDA has issued warnings relating to Kellogg's Honey Smacks, romaine lettuce and certain drugs including Angiotensin II receptor blockers.During fiscal 2018, there were 7,420 recalls with 831 classified as high risk.

It is anticipated that the application of advanced technology including whole genome sequencing will allow state and federal health officials to detect foodborne disease outbreaks, match them to a product or facility and trace contamination to source.

In the accompanying comments, FDA commissioner Dr. Scott Gottlieb noted "I remain committed to investing in the FDA recall and outbreak programs, building on our successes and applying the FDA leadership and expertise to protect American families and keep our nation safe."